- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02289248
Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Intravenous Ketamine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Connecticut
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New Haven, Connecticut, United States, 06519
- Connecticut Mental Health Center
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New Haven, Connecticut, United States, 06519
- Yale Psychiatric Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- suffering from a depressive episode (DSM 5; either Major Depressive Disorder or Bipolar Disorder) and having failed one or more standard antidepressant treatments during the current episode;
- Age 18-65;
- Hamilton Depression Rating Scale (17-HAM-D) score of 21 or more prior to study entry.
Exclusion Criteria:
- Any Axis I or Axis II Disorder, which at screening is clinically predominant to their depressive episode or has been predominant to their depressive episode at any time within 6 months prior to screening;
- Active suicidal thoughts with a plan; current or recent (<6 months ago) substance use disorder;
- Non-affective psychosis (such as schizophrenia or schizoaffective disorder);
- Pregnancy or breastfeeding;
- Inability to speak English fluently;
- A clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results;
- A history of CBT treatment in the past 12 months;
- Dementia;
- Delirium;
- Any other neurological or mental disease that might affect cognition or the ability to meaningfully participate in CBT.
- Untreated hypertension as defined by a systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening on two of three measurements.
- Recent myocardial infarction (within one year)
- Syncopal event within the past year.
- Congestive heart failure (CHF) New York Heart Association Criteria >Stage 2
- Angina pectoris.
- Heart rate <50 or >105 beats per minute at screening
Females are eligible provided they meet criteria A or B below:
- Non-childbearing potential: e.g., physiologically incapable of becoming pregnant, i.e., permanently sterilized (status post hysterectomy, bilateral tubal ligation), or is post-menopausal with her last menses at least one year prior to screening; or
- Childbearing potential, and meets the following criteria:
i. Childbearing potential, including women using any form of hormonal birth control, on hormone replacement therapy started prior to 12 months of amenorrhea, using an intrauterine device (IUD), having a monogamous relationship with a partner who has had a vasectomy, or is sexually abstinent.
ii. Negative urinary pregnancy test at screening, confirmed by a negative urinary pregnancy test at enrollment prior to receiving study treatment.
iii. Willing and able to continuously use one of the following methods of birth control during the course of the study, defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly: implants, injectable or patch hormonal contraception, oral contraceptives, IUD, double-barrier contraception, sexual abstinence. The form of birth control will be documented at screening and baseline.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketamine/CBT Group
Subjects will undergo 2 week course of 4 intravenous infusions of ketamine (given twice weekly for two weeks) in combination with twice weekly cognitive behavioral therapy for a total of 8 weeks.
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Subjects will undergo a twice weekly two week course of IV infusions of ketamine
Subjects will undergo twice weekly CBT for a total of 8 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extinction Learning Task performance
Time Frame: 24 hours Post ketamine infusion
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Hopkins Verbal Learning Test and extinction learning tasks will be administered both one week before and 24-hours after the first ketamine infusion and the change in scores compared.
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24 hours Post ketamine infusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 8 weeks
|
Change in MADRS from baseline through week eight using a random effects model
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samuel Wilkinson, MD, Yale University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Depression
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- 1501015171
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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